Questionnaire ISO 13485
During the implementation of a quality system, and in the preparation for an audit, it makes sense to use a questionnaire to ascertain whether all topics from the standard are covered. We have drawn up a questionnaire for our own use. This questionnaire is updated and improved over many years of practical use. In over 300 questions the entire ISO 13485: 2016 standard is assessed.
A free evaluation version is available to give you an impression on the design and content of this questionnaire.
This free version covers the following standard paragraphs:
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4.1
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General requirements
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4.2.2 | Quality manual |
| 5.3 | Quality policy | |
| 6.2 | Competence, awareness and training | |
| 6.3 | Infrastructure | |
| 7.4.1 | Purchase process |
A full questionnaire can be ordered by using our order form.